Clinical Trial Assistant

5 days ago

Netherlands

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Job Description

ICON is seeking a Clinical Trial Assistant in the Hague area, Netherlands. The role involves coordinating study activities, ensuring document submission to regulatory bodies, and maintaining the local eTMF. Candidates should have administrative experience in the medical field, strong organizational skills, and fluency in Dutch and English. The position is full-time with a focus on quality and compliance in clinical trials.
We are looking for CTA based in the Netherlands (in the the Hague area)

The Clinical Trial Assistant assists in the coordination and administration of the study activities from the start up to execution and close out, and within the Local Study Team to ensure quality and consistency of interventional study deliverables to time, cost and quality objectives

Assists in timely submission of proper application/documents to EC/IRB and, where appropriate to Regulatory Authorities for the duration of the study.
• Interfaces with Investigators, external service providers and CRAs during the document collection process to support effective delivery of a study and its documents.
• Serves as local administrative main contact and works closely with the CRAs and/or the LSAD for the duration of the study.
• Operational responsibility for the correct set-up and maintenance of the local eTMF and ISF including document tracking in accordance with ICH-GCP and local requirements.
• Ensures essential documents under their responsibility are uploaded in a timely manner to maintain the eTMF “Inspection Readiness”.
• Ensures that all study documents are ready for final archiving and completion of local part of the eTMF and supports the CRA in the close out activities for the ISF.
• Contributes to the production and maintenance of study documents, ensuring template and version compliance
• High school/Secondary school qualifications (*), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers.
• Previous administrative experience preferably in the medical/ life science field.
• Proven organizational and administrative skills.
• Computer proficiency.
• Speaking fluently the Dutch and English language

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

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About this company

Website:flaticon.com

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